MedTrace Logo

Noninvasive Screening for Affected Pregnancies: Assay Development & Optimization in Affected Pregnancies

NCT01052688 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2021-09-20

No results posted yet for this study

Summary

To collect samples for the purpose of developing and optimizing an in vitro noninvasive prenatal diagnostic (NIPD) test. The NIPD test employs circulating cell free (ccff) DNA extracted from whole blood samples collected from women who are pregnant with a fetus previously determined to have a chromosomal abnormality. The NIPD result will be compared to the standard test results obtained from other test methods such as karyotype, FISH, QF-PCR, and/or any commercially available NIPD test.

Conditions

  • Down Syndrome
  • Aneuploidy

Interventions

OTHER

Maternal blood draw of 30 to 50ml

Maternal blood draw of 30 to 50mls during pregnancy. Blood may be drawn up to 5 times during the pregnancy between weeks 8 and 36 gestation.

Sponsors & Collaborators

  • Sequenom, Inc.

    lead INDUSTRY

Principal Investigators

  • Juan-Sebastian Saldivar, M.D. · Sequenom, Inc.

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2021-08-31
Completion
2021-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01052688 on ClinicalTrials.gov